Submit a new study – required documents and information
Contract and budget negotiation.
The Clinical Trials Office (CTO) negotiates contracts and budgets of
clinical trials whose Principal Investigator has a primary
appointment in the
College of Physicians and Surgeons.
Research Administration negotiates contracts and budgets of
clinical trials whose Principal Investigator has a primary appointment in
the Mailman School of Public Health, the College of Dental Medicine,
or the School of Nursing.
Step 1.
All sponsored research projects must first be registered through the
RASCAL Grants & Contracts Module.
Log in to
RASCAL,
create a proposal,
obtain a RASCAL "Proposal Trak ID" , e.g., "PT-AAAG1234",
and upload to RASCAL
the complete protocol,
a draft budget,
and a draft contract.
Step 2. Review
these questions,
which will help the CTO process your study.
Step 3. Complete CTO required forms.
• Compliance Statement
(Preview form)
• Questionnaire (v. 2008)
(Preview form)
• Tax Exemption Certification (v. 2008)
(Preview form)
Step 4. Complete these additional forms where applicable.
| • |
Research Pharmacy Cost Estimate Request Form
(Preview form)
| | The Research Pharmacy Cost Estimate Request Form allows the Research Pharmacy
to provide investigators
with a more accurate estimate of costs associated with the procurement and
distribution of pharmaceuticals.
If your proposal does not require Research Pharmacy assistance
—
e.g., the proposed study is a device trial rather than a drug trial
—
continue to the
Budget Worksheet and instructions
for budget preparation.
Please note:
investigators requiring cost estimates from the New York State
Psychiatric Institute's Research Pharmacy should call the
Contracts Department at (212) 305-3360.
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| • | Budget Worksheet and Instructions (Preview form)
| | The CTO Finance department must approve all budgets prior to contract
execution. The budget worksheet and instructions are provided as a guide to improve
discussions with this department. The CTO Finance Budgets team members are continually
apprised of all changes in New York-Presbyterian Hospital ChargeMaster program
and can assist investigators in using the appropriate fees.
|
Submit an Amendment –
required documents and information
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Submit an Amendment
(Preview form)
| |
To amend an existing study already on file, you must provide the
following documents
and information:
– Principal investigator name and contact information
– CU IRB #
– Abbreviated title
– Sponsor name and contact information
– Clinical Research Organization (CRO) name and contact information
(if applicable)
– Electronic copies of
amendment
and
any amendment-related correspondence from sponsor
|
Submit a Confidential Disclosure Agreement (CDA)
| • |
Submit a CDA
(Preview form)
| |
A Confidential Disclosure Agreement (CDA)
is a legal contract
that defines the terms and criteria used to assure that
a study sponsor and Columbia University
will maintain the confidentiality of study-related information
—
e.g., data, methods, and procedures
—
and will not use this information
for any purpose other than that described in the CDA.
To submit a CDA, you must provide the following documents and information:
– Principal investigator name and contact information
– CU IRB #
– Abbreviated title
– Type of funding: external or internal
– Sponsor name and contact information
– Clinical Research Organization (CRO) name and contact information
(if applicable)
– Electronic copies of
CDA
and
any CDA-related correspondence from sponsor
Read CUMC's standard operation procedures for executing CDAs
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